QHGClass II
Defect Measurement Tool
21 CFR 888.4510 / Orthopedic
QHG is the FDA product code for Defect Measurement Tool, a class II device type, regulated under 21 CFR 888.4510. FDA's definition for this code reads: "Manual surgical instrument for appropriate patient select for orthopedic implant is a device used to measure an anatomical feature(s) to determine appropriate patient selection for an orthopedic implant. The characteristics of the instrument are defined by the specifications set for use of the orthopedic implant in...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QHG
- Device name
- Defect Measurement Tool
- FDA definition
- Manual surgical instrument for appropriate patient select for orthopedic implant is a device used to measure an anatomical feature(s) to determine appropriate patient selection for an orthopedic implant. The characteristics of the instrument are defined by the specifications set for use of the orthopedic implant in terms of geometry, surgical technique, and use of the device.
- Regulation
- 21 CFR 888.4510
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QHG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2020 | 1 |
Applicants with the most clearances
Product code QHG| Applicant | Clearances |
|---|---|
| Intrinsic Therapeutics, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.